Voice Tessitura and Size of the Required Laryngeal Mask

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03619057

Acronym

EVG

Enrollment

161

Registered

2018-08-07

Start date

2018-10-01

Completion date

2019-09-24

Last updated

2020-07-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Laryngeal Masks

Brief summary

The choice of the size of the laryngeal mask (i-gel) is based on the weight. Even following the weight recommendations, it is quite common to choose a mask that is too big or too small, which leads to ventilation leaks (too small), or insertion failures (too big) and leads to a change of mask for bigger or smaller. The i-gel are laryngeal masks (2nd generation) which consist of gel and have been designed by molding on larynx corpses. The masks are not inflatable (so not adaptable). I-gel masks are used in adult and pediatric patients for weights ranging from 2 Kg to over 90 Kg to provide ventilation during general anesthesia. Patients with a deep voice probably need a larger laryngeal mask than their weight alone suggests. The investigators propose to measure the lowest sound emitted by the patient because it would seem logical that the larger the larynx is, the more the voice is serious. This hypothesis will be verified a posteriori by the size of the laryngeal mask used and adapted by comparing it to the range of the voice.

Interventions

OTHERGeneral anesthesia with laryngeal mask i-gel

General anesthesia with laryngeal mask i-gel

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

10 Years to No maximum

Healthy volunteers

Inclusion criteria

* Age ≥ 10 years * Planned surgical procedure with the use of a laryngeal mask

Exclusion criteria

• Refusal to participate in the study.

Design outcomes

Primary

Measure	Time frame	Description
Concordance between the weight and the tessitura threshold	1 day	Concordance between the size of the mask proposed as a function of the weight and that determined after determination of the tessitura threshold for each mask size by ROC curves.

Secondary

Measure	Time frame	Description
Determining the tessitura threshold corresponding to each mask size	1 day	tessitura threshold (the most serious sound emitted by the patient) corresponding to each mask size

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026